Breast cancer is one of the most common forms of cancer in women. A key to treatment is early detection. For example, annual mammograms have been recommended in hopes of early detection of breast cancer. One problem with mammographic imaging is that it can only detect breast cancer once it has taken tangible form as a tumor. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited. Therefore, more sensitive and reliable methods and devices are needed to detect cancerous, pre-cancerous, and other cancer indicators of the breast at an early stage. Such methods and devices could significantly improve breast cancer survival. While breast cancer is most common among women, in rare instances breast cancer can occur in men.
A vast majority of breast cancers reportedly begin in the lining of mammary ducts. Studies have indicated that fluid within the mammary ducts can contain high levels of breast cancer markers, and that an estimated 80% to 90% of all breast cancers occur within the intraductal epithelium of the mammary glands. The fluid within the breast ducts contains an assemblage and concentration of hormones, growth factors and other potential markers comparable to those secreted by, or acting upon, the surrounding cells of the alveolar-ductal system. Mammary fluid also typically contains cells and solid cellular debris or products that can be used in cytological or immunological assays for breast cancer.
An early method of detecting breast cancer based on analysis of mammary fluid involves analyzing a sample of mammary fluid that was excreted by the mammary ducts without outside intervention. In other words, if a mammary duct is actively discharging a fluid, this fluid is analyzed. Often breasts do not discharge fluid spontaneously, even though breast cancer markers may be present in the mammary fluid.
One such diagnostic procedure based on the analysis of mammary fluid is ductal lavage. This method entails introducing saline into the mammary ducts via a small catheter and removing the introduced saline solution from the mammary ducts by vacuum. The recovered fluid is then subjected to immunological or cytological evaluation for the presence of breast cancer markers. This is a delicate procedure requiring considerable skill on the part of the clinician performing the catheterization. One advantage of such methods is that fluid samples can be retrieved from individual ducts, thus facilitating location of the cancerous area within the breast. One difficulty with such procedures is that they involve introduction of a catheter into the very small ducts in the breast nipple. Maintaining the breast in a suitable stable position during the catheterization and lavage procedure can be troublesome.
In situations where surgical intervention is required, for example to remove mammary ducts, maintaining the breast in a suitable stable position for the duration of the surgery is important. The breast can be manually held in position by a surgical assistant, for example with the aid of clamps and forceps. However, surgical procedures can be lengthy, and the assistant may be required to manually hold the breast in position for an extended period of time with attendant fatigue.
The present invention provides a device and kit for stabilizing and positioning a human breast for diagnostic or surgical procedures with minimal manual intervention to maintain the breast in a suitable position during the procedure.